image credit: The U.S. FDA / Wikimedia

FDA rejects rare disease drug, asks for prefilled syringe info

March 16, 2021


The FDA has rejected PharmaEssentia’s request for approval of a treatment for a rare blood cancer. PharmaEssentia needs to provide more information about the instructions for the prefilled syringes used to administer the pegylated interferon.

Ropeginterferon alfa-2b, which is sold in the EU as Besremi, comes in prefilled syringes for injection under the skin. The drug is designed to bind to interferon-alpha/beta receptors, thereby triggering processes that drive a reduction in red blood cell production in the bone marrow. As the rare disease polycythaemia vera is defined by excess red blood cells, PharmaEssentia sought to win FDA approval in the indication.

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